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VOCARE vitals360, User Manual

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VOCARE vitals360 User Manual Download Page 8

Instructions for Use     

Page 

8 

of

  117

 

01 IMPORTANT SAFETY INFORMATION     
 

•

 

The  user  must  carefully  read  and  fully  understand  the  instructions  for  use  contained  in  the  USER 
MANUAL before operating the device. 

•

 

To  ensure  proper  operation  of  the  device,  and  correct  test  results,  the  instructions  and  warnings 
contained in the USER MANUAL must be carefully reviewed and followed prior to and during operation 
of the device. 

•

 

Keep this USER MANUAL in the vicinity of the device so that it can be easily referenced. 

 
The following symbols are referenced in the USER MANUAL, QUICK START GUIDE, LABELING, PACKING and 
must be fully reviewed and understood prior to use of the device: 
 

 

WARNINGS

 

Indicates a potentially hazardous situation which, if NOT avoided, could result in death or serious injury. 
 

 

CAUTION 

Indicates a potentially hazardous situation which, if NOT avoided, may result in minor or moderate injury to the 
user or patient or damage to the device or other property. 
 

NOTES

 

Contain important information that may be overlooked or missed. 
 

 

CONSULT INSTRUCTIONS FOR USE 

Indicates the need for the user to consult the instructions for use. 
 
 

 

Summary of Contents for vitals360

Page 1: ...Instructions for Use Page 1 of 117 ...

Page 2: ... 01 10 Inappropriate Storage 15 01 11 Care Maintenance 16 01 12 Environmental Protection Discard 16 01 13 Risk of Electrical Shock AC Adapter Usage 16 01 14 Battery Use Safety 18 01 15 Display Touch Screen 19 02 DEVICE OVERVIEW 20 02 1 Know Your Monitor 20 02 2 Unpacking Checking 23 02 3 Test Operating Mode Selection 24 02 4 Intended Use 29 02 5 Accessories 29 03 BEFORE MEASURING 30 03 1 Using the...

Page 3: ...Cuff 48 04 5 For Accurate Measurement 49 04 6 Taking A Reading 52 04 7 Read the Blood Pressure Display 55 04 9 Troubleshooting 56 05 MEASURING BLOOD OXYGEN SPO2 57 05 1 Overview 57 05 2 Safety Information 58 05 3 Display Symbols Bank 61 05 4 Taking A Reading 62 05 5 If Using Oxygen 64 05 7 Troubleshooting 66 06 MEASURING FOREHEAD TEMPERATURE 67 06 1 Overview 67 06 2 Safety Information 67 06 3 Disp...

Page 4: ...cessing 85 10 2 View the Measuring Result 85 10 3 Display Symbols Bank 86 10 4 Check the History 86 11 INTRODUCE 88 12 MODE SWITCHING 89 13 CLEANING DISINFECTING 90 13 1 The Difference between Cleaning Disinfecting 90 13 2 Safety Information 90 13 3 How to Clean the Device 91 13 4 How to Disinfect the Device 93 13 5 Approved Cleaning Disinfecting Product 94 13 6 How to Clean Disinfect the Arm Cuff...

Page 5: ... 16 5 Precautions for Transfer and Disposal 105 16 6 End User License Agreement for Software 105 17 COMPLIED STANDARDS LIST 108 18 IEC60601 1 2 EMC RF STATEMENT 110 IMPORTANT INFORMATION REGARDING ELECTRO MAGNETIC COMPATIBILITY EMC 110 GUIDANCE MANUFACTURER S DECLARATION 111 ...

Page 6: ...nect with most wireless carriers There are three modes in which the device can be used spot checking in the field checking vital signs in a clinical setting and checking vital signs by the patient or lay person in a remote location In the first scenario the healthcare provider takes the device into the field and uses the device as a standard medical device for spot checking patient vital signs In ...

Page 7: ...given or otherwise shipped to a patient or layperson who uses it at home to check their vital signs The measured vital signs are associated with that patient and stored in the third party MDDS The operating mode corresponding to this scenario is called Test and Share Mode ...

Page 8: ...vice so that it can be easily referenced The following symbols are referenced in the USER MANUAL QUICK START GUIDE LABELING PACKING and must be fully reviewed and understood prior to use of the device WARNINGS Indicates a potentially hazardous situation which if NOT avoided could result in death or serious injury CAUTION Indicates a potentially hazardous situation which if NOT avoided may result i...

Page 9: ...e Page 9 of 117 01 1 Symbols Bank TAP SELECT TAP HOLD PRESS SWIPE UP DOWN PRESS SWIPE FORWARD BACKWARD ENTER TEXT OR NUMBER IN CAUTION Federal law restricts this device to sale or use on the order of a healthcare provider ...

Page 10: ...e or humidity difference 01 3 Electromagnetic RF Immunity WARNINGS DO NOT expose or use the device in an MRI or CT environment The induced current could cause burns to the user DO NOT use the device in the presence of high power appliances such as high voltage cables X ray machines ultrasound equipment or a defibrillator DO NOT use the device under the conditions of a strong electromagnetic field ...

Page 11: ...it electromagnetic fields near the device This may result in incorrect operation of the device Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary this equipment and the other equipment should be observed to verify that they are operating normally ...

Page 12: ...xpose the device to electric shocks DO NOT expose the device to any static electricity CAUTION To prevent electrostatic damage to the device ensure that your body is free of static electricity before using the device Static electricity can damage electronic components contact with earthed objects or devices will discharge the energy that has built up and cause electrostatic discharge ...

Page 13: ...ounds when exceeding a limit DO NOT use the device in critical situations or where alarms are required In case of emergency immediately contact your local emergency services 01 7 Human Exposure All materials used in the device that the patient will be in contact during use have been tested and found to comply with the requirements of ISO 10993 STANDARD The software was developed in compliance with...

Page 14: ...fficiently charged to avoid startup abnormalities or inaccurate data measurements Remain still during measurement DO NOT move your body or arms DO NOT speak talk to avoid affecting the accuracy of the measurement The device may NOT work for all patients If you are unable to achieve stable readings please discontinue use and discuss with your healthcare provider 01 9 Self Diagnosis WARNINGS All med...

Page 15: ...r regardless of the measurement results If you are taking medication consult your healthcare provider to determine the most appropriate time to measure your physiological data NEVER change prescribed medication without consulting your healthcare provider The device is NOT a substitute for seeking medical attention If you believe you are experiencing any adverse medical event seek immediate medical...

Page 16: ...NICIPAL WASTE The disposal of scrap device and its accessories and packing including battery plastic bags foams and paper boxes should follow the local laws and regulations For environmental reasons unlawful disposal may cause environmental pollution If you have any questions concerning the disposal of the device we recommend contact your local VOCARE INC representative or call 1 855 986 2273 For ...

Page 17: ...arge station to any power source or external equipment other than described in this USER MANUAL DO NOT disassemble crush puncture shred or otherwise attempt to modify the battery DO NOT put pressure on the battery as this can cause leakage or an internal short circuit resulting in overheating fire or explosion DO NOT let the device or battery come in contact with liquids Liquids can get into the d...

Page 18: ...ly on a hard surface can damage the device and battery If you suspect damage to the device or battery take it to your local VOCARE INC representative for inspection or call 1 855 986 2273 NEVER use any battery that is damaged in any way DO NOT allow the battery to touch metal objects Accidental short circuiting can occur when a metallic object coin key jewelry clip or pen causes a direct connectio...

Page 19: ... broken or cracked as this could cause injury WARRANTY DISCLAIMER PROPER USE OF A TOUCH SCREEN DEVICE The device has a touch screen display please note that a touchscreen responds best to a light touch from the pad of your finger or a non metallic stylus Using excessive force or a metallic object when pressing on the touchscreen may damage the tempered glass surface and void the warranty For more ...

Page 20: ...Instructions for Use Page 20 of 117 02 DEVICE OVERVIEW 02 1 Know Your Monitor a Device ...

Page 21: ...Instructions for Use Page 21 of 117 b Arm Cuff CAUTION To ensure accurate measurements VOCARE INC recommends annual replacement of the arm cuff c AC Adapter ...

Page 22: ...Instructions for Use Page 22 of 117 d Type C Cable e SIM Card CAUTION The SIM Card is installed in the device by the manufacturer before packing f User Manual g Quick Start Guide h Carrying Case ...

Page 23: ...llowing parts are provided in the package ITEM QTY CHECK a VITALS360 Device 1 b Arm Cuff 1 c AC Adapter 1 d Type C Cable 1 e SIM Card 1 f User Manual 1 g Quick Start Guide 1 h Leather Carrying Case 1 CAUTION If any of these items are missing from your kit contact your local VOCARE INC Representative or call 1 855 986 2273 ...

Page 24: ...vice the Healthcare Provider must select an operating mode The device will operate in one of the three test modes Single Test Mode Multi test and Share Mode and Test and Share Mode An individual may switch between the operating modes subject to the following rules NOTES a remote patient is not allowed to change the operating mode from Test and Share ModError R eference source not found to another ...

Page 25: ...ble Multi test and Share Mode TAP SELECT Multi test and Share button on the screen and you will go to the home page of Multi test and Share Mode This mode mimics Test and Share Mode with the exception of being used for multiple individuals with thorough cleaning of the device required between uses In Multi test and Share Mode the device must not only measure but also store vital sign measurements ...

Page 26: ...e device in Multi test and Share Mode The Healthcare Provider might leave for field work to an area without network connection yet forgets to switch to Single Test Mode before leaving It will be possible for the Healthcare Provider to exit Multi test and Share Mode and enter Single Test Mode once the Healthcare Provider arrives at their destination 6 When the Healthcare Provider exits Multi test a...

Page 27: ...e selected patient identifier and displays the main menu from where the Healthcare Provider or patient may select measurements to perform 4 The device will require the Healthcare Provider or patient to authenticate in order to enter or exit Test and Share Mode NOTES a In order to give access to patient data the device must establish that the user is a Healthcare Provider or patient In order to giv...

Page 28: ... not realize that there are measurements stored on the device which will be lost if he or she exits Test and Share Mode 8 The device will allow the Healthcare Provider or patient to cancel exiting Test and Share Mode if offline measurement data could be lost NOTES a The Healthcare Provider or patient might decide to postpone this action until a network connection is available and the offline measu...

Page 29: ...ained adults only who can use smartphones proficiently This VITALS360 device is intended for use in a clinical or home environment This VITALS360 device is a reusable device following thorough cleaning between uses CAUTION Federal law restricts this device to sale or use on the order of a healthcare provider 02 5 Accessories Reusable Cuff Patient Category Measurement Site Limb Circumference Adult ...

Page 30: ...rtical or floor mount position Use ONLY the authorized VITALS360 AC Adapter included with this device If the AC Adapter is disconnected while the device is being used the measurement results will NOT be deleted CAUTION Use ONLY VITALS360 authorized parts and accessories Parts and accessories NOT approved for use with the device may damage the device To disconnect the AC Adapter unplug the AC Adapt...

Page 31: ...Instructions for Use Page 31 of 117 03 2 Turn On Off TAP HOLD the switch button for more than 3 seconds and the device will power off when device is turned on ...

Page 32: ...Instructions for Use Page 32 of 117 03 3 Symbols Items Bank Symbols App OS Status Bar Symbols Items Switch Mode Single Test Mode Multi test and Share Mode Test and Share Mode ...

Page 33: ...Action Items 03 4 Login Single Test Mode 1 TAP SELECT the Single Test Mode button on the screen and you will go to the home page of this particular test mode 2 Swipe forward and backward to navigate between screens and find more functions ...

Page 34: ...evice prompts the Healthcare Provider for username and password 4 The Healthcare Provider fills in the username and password and clicks Login 5 The device authenticates the user based on the entered username and password 6 If authentication is successful then the device allows for execution of the Multi test and Share Mode functionality Test and Share Mode 1 TAP SELECT the Test and Share button on...

Page 35: ...d 4 The Healthcare Provider fills in the username and password and clicks Login 5 The device authenticates the user based on the entered username and password 6 If authentication is successful then the device allows for execution of the Test and Share Mode functionality 03 5 Display of Home Page App Operation System Status Bar Time Main Function Symbols Area Main Function Symbols Area ...

Page 36: ...Instructions for Use Page 36 of 117 Home Button Back Button returns to the previous screen ...

Page 37: ...Instructions for Use Page 37 of 117 03 6 Symbols Bank Home Page LANGUAGES ...

Page 38: ...s for Use Page 38 of 117 03 7 Symbols Bank Setting 03 8 User Setting TAP SELECT the button Setting and launch the User Setting Page CAUTION Set up the device to the correct date and time before the first measuring ...

Page 39: ...aker TAP SELECT the volume icon to turn off device volume if desired CAUTION Please be aware when choosing to turn off the volume of the device you will not be able to hear the beep sound when a measurement starts and finishes 03 10 Setting Unit of Measurement Switch Swipe forward and backward the Unit button measurement selection to switch the unit of the measurements between Metric or English st...

Page 40: ...anguage icon for more than 1 secondand the Language selection page will appear TAP SELECT the Language to be utilized and the language on the screen will change CAUTION The device may be used in English French Chinese Spanish and Arabic The device default language is English ...

Page 41: ...03 12 Setting ECG TAP HOLD the ECG icon more than 1 second and the icon will be highlighted in green and go to the ECG setting page CAUTION Consult your healthcare provider before adjusting the device s ECG Setting 03 13 Setting Date Time ...

Page 42: ...n will be highlighted in green and go to the Date Time setting page TAP SELECT the Text to 1 Set up the Date 2 Set up the Time and Time Format 03 14 Setting Admin Setting TAP HOLD the Admin Setting icon for more than 1 second and the icon will be highlighted in green and go to the Admin Setting ...

Page 43: ...Use Page 43 of 117 TAP SELECT Clear History to clear the measuring history records in the device if necessary Administrator Test Mode is a function is to be utilized ONLY by the manufacturer or VITALS360 representative ...

Page 44: ...2 35 cm Pressure range 0 300mmHg SYS Measurement range 60 230mmHg DIA Measurement range 40 130mmHg PR range 40 180bPm Color coded and audible Information The device is designed to give you an easy indication reading with color measuring results which illuminate after taking the reading RESULTS COLOR MEANING SYS 91 139 mmHg DIA 61 89 mmHg Green Acceptable Other readings Red Consult a healthcare pro...

Page 45: ...ice or arm cuff This may cause an inaccurate reading or injury This device is NOT suitable for continuous monitoring during medical emergencies or operations DO NOT use the device for any purpose other than measuring blood pressure or other function in this device This device is NOT intended for treatment If you are taking medication consult your healthcare provider to determine the most appropria...

Page 46: ...Use Page 46 of 117 For patients with high mental anxiety self measurement of blood pressure is NOT recommended DO NOT use on people with sensitive skin or allergies This may result in exanthema skin irritation or eczema ...

Page 47: ...Instructions for Use Page 47 of 117 04 3 Display Symbols Bank Systolic Blood Pressure Result Pulse Rate Diastolic Blood Pressure Result Pulse Rate Result ...

Page 48: ...eve ensure it DOES NOT cause constriction of the blood flow in the upper arm Position the tube outlet so that it is on the palm side of the arm in line with the littler finger of the hand Be sure to close the clamp tightly to cut off the air flow into the tube The arrow should be centered on the inside of the arm and aligned with your middle finger DO NOT wrap clothes into the arm cuff strap as th...

Page 49: ...for Use Page 49 of 117 04 5 For Accurate Measurement Blood Pressure Differences When Lying Down Standing Up And Sitting Accurate blood pressure measurements may be obtained in a number of ways There are three common ...

Page 50: ...k to pump blood to our brain when we are lying down This is because our head is about the same level as our hearts However when we are up our head is a lot higher than our heart This means the heart has to pump much harder to get blood to our brain so as a result blood pressure is higher In most cases blood pressure is taken while a person is sitting down with the arm dropping onto a table While s...

Page 51: ...ition with your legs crossed It increases systolic pressure by as much as 8 mmHg Remain calm for approximately 4 to 5 minutes before taking measurements Relax and stay in a natural posture when taking measurements Keep quiet during measurement to avoid impacting the accuracy of the measurement Keep the device in a stable position to ensure that it DOES NOT shake during the test DO NOT inflate the ...

Page 52: ... 117 04 6 Taking A Reading 1 TAP SELECT the Blood pressure button 2 Select and the icon that best matches the position you will be in when measuring 3 TAP SELECT the button representing the arm you are taking your blood pressure from ...

Page 53: ...ons for Use Page 53 of 117 4 The icon will be highlighted in Green to match your selection of position being used Inflate Deflate 5 Complete Beep occurs when measurement starts and finished 6 Remove the arm cuff ...

Page 54: ...shake during the test DO NOT move your body or arms DO NOT speak during testing Remain calm and still during testing to avoid impacting the accuracy of the measurement DO NOT measure the same arm continuously If multiple measurements are needed the interval between the two measurements should be at least 30 Seconds Wait Several Minute s after urinating before taking measurements NOTES Remain still...

Page 55: ...55 of 117 04 7 Read the Blood Pressure Display The blood pressure value and pulse are displayed at the same time Blood pressure values are displayed alternately in mmHg units 04 8 Illustrated Example of Measuring Blood Pressure ...

Page 56: ...Instructions for Use Page 56 of 117 04 9 Troubleshooting ...

Page 57: ...SpO2 percentage Each hemoglobin molecule can carry a load of four oxygen atoms and SpO2 is the sum percentage of hemoglobin molecules which are oxygen rich An experience formula of data process is established taking use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive Hemoglobin HbR and Oxyhemoglobin HBO2 in red light and near infrared light zones The photoelectric...

Page 58: ...onsult a healthcare provider Linear Regression plot of SpO2 vs SaO2 05 2 Safety Information WARNINGS DO NOT measure with the environment temperatures below 41 5 or above 95 35 DO NOT measure with humidity below 10 or above 95 The device and Blood Oxygen function are NOT designed to be used by anyone less than 18 years of age DO NOT expose or use the device in an MRI or CT environment The induced c...

Page 59: ...ronments For those with a substantial amount of staining dilution drug such as Methylene Blue Indigo Green and Acid Indigo Blue or Carbon Monoxide Hemoglobin COHb or Methionine Me Hb or this Salicylic Hemoglobin or Carboxyhemoglobin or Methemoglobin and some with icterus issues the SpO2 result from the device may be inaccurate The drugs like dopamine procaine prilocaine lidocaine and butacaine may...

Page 60: ... possible Obstructions or dirt on the sensor s red light or detector may cause sensor failure Make sure there are NO obstructions and the sensor is clean DO NOT pour liquid on to the device or the sensor and light tube When a trend toward patient deoxygenation is indicated blood samples should be analyzed by a laboratory co oximeter for a full diagnosis of the patient s condition based on advice f...

Page 61: ...Instructions for Use Page 61 of 117 05 3 Display Symbols Bank Pulse Rate Waveform ...

Page 62: ...Taking A Reading 1 TAP SELECT the Blood Oxygen button 2 TAP SELECT whether you are or are not using Oxygen before measuring 3 Open the clamp and insert a finger into the SpO2 door as illustrated Then gently release the clamp to start measuring ...

Page 63: ...ay liquids onto the SpO2 door and DO NOT allow any liquid to enter any openings in the device Make sure the device thoroughly dry prior to each use Always stay calm and quiet for approximately 4 to 5 Minutes before taking measurements Sit down and keep your back straight and your feet flat on the floor Please be sure your legs are NOT crossed The index finger middle finger or ring finger are suita...

Page 64: ...Instructions for Use Page 64 of 117 05 5 If Using Oxygen 1 TAP SELECT Using Oxygen button 2 PRESS SWIPE UP and DOWN to select how much oxygen used before measuring 3 TAP SELECT button to go to next page ...

Page 65: ...er into the SpO2 door as illustrated Then gently release the clamp to start measuring 5 When the finger is inserted into the device it will measure and display SpO2 and pulse rate real time results 6 Measurements will be obtained and displayed in approximately 30 Seconds ...

Page 66: ...Instructions for Use Page 66 of 117 05 6 Illustrated Example of Measuring Blood Oxygen Saturation 05 7 Troubleshooting ...

Page 67: ...OT measure with humidity below 10 or above 95 EXPLOSION HAZARD DO NOT use the device in the presence of flammable anesthetics mixed with air oxygen or hydrogen such as in a hyperbaric chamber ultraviolet sterilizer or oxygen tent The device and forehead temperature function are NOT designed for people less than 18 years of age NOT for use on critically ill patients patients in shock dehydrated pat...

Page 68: ...val between each measurement Apply device to forehead to obtain measurement The protective glass over the lens is the most fragile part of the device thermometer DO NOT touch the tip of the temperature probe which houses a precise temperature sensor Keep the temperature probe clean to ensure accurate readings Clean the thermometer after each use Please refer to Chapter 13 Cleaning Disinfection for...

Page 69: ... 1 TAP SELECT the Temperature button 2 TAP SELECT button and place the temperature sensor on the forehead The measurement starts in 5 seconds Hold the device placing the temperature sensor on the forehead 3 Beep will occur when measurement starts and finishes ...

Page 70: ... Hour and keep a quiet for while after hard exercise or a hot bath to take body temperature DO NOT take measurements if your skin is wet Wait at least at least 20 Minutes to take measurements after coming in from cold places Wait at least 20 Minutes after light exercise or if you smoke or drink a hot or cold liquid Make sure the skin on your forehead is dry and clean before taking each measurement...

Page 71: ...Instructions for Use Page 71 of 117 06 5 Illustrated Example of Measuring Forehead Temperature 06 6 Troubleshooting ...

Page 72: ...Instructions for Use Page 72 of 117 ...

Page 73: ...sure with the environment temperatures below 41 F 5 C or above 95 F 35 C DO NOT measure with humidity below 10 or above 95 The device and ECG function are NOT designed to be used for anyone less than 18 years of age DO NOT expose or use the device in an MRI or CT environment The induced current could cause burns to the user DO NOT allow the electrodes of the device to come into contact with other ...

Page 74: ...and the skin are expected to influence the quality of the measurements DO NOT take a recording if the electrodes are dirty Clean them first DO NOT pour liquid on to the device or the electrodes This device monitors and records ECG waveforms it DOES NOT detect or measure all heart rate heart rhythm and heart waveform changes especially those related to ischemic heart conditions NOTES The device is ...

Page 75: ...he recording speed of ECG sweep speed Speed settings 25mm s and 50mm s ECG GAIN Speed setting 5mm s 10mm s and 20mm s ELECTROCARDIOGRAPH An instrument used in the detection of heart abnormalities It measures electrical potentials on the body surface and generates a record of the electrical currents associated with heart muscle activity HEART RATE HR The number of heartbeats per unit time usually i...

Page 76: ...7 4 Taking A Reading 1 TAP SELECT the ECG button 2 TAP SELECT the button 3 Place right and left thumbs gently on the electrodes Remain calm and relaxed with regular breathing Measurements can be taken from approximately 60 second intervals ...

Page 77: ...tly Please read the instructions carefully before taking a measurement Make sure that the electrodes are directly touching your skin If your hands are too dry wipe them with a damp towel so that they are slightly moist If the electrodes are dirty wipe any dirt off with a soft cloth moistened with disinfectant alcohol or a cotton swab DO NOT move during the measurement Movement including talking co...

Page 78: ...Instructions for Use Page 78 of 117 07 5 Illustrated Example of Measuring ECG 07 6 Troubleshooting ...

Page 79: ...ient s weight automatically The device also has no sensors capable of measuring the user s height automatically Since the user s weight may be closely related to the user s height the Vitals360 device provides a method to record both the weight and height manually The user must measure weight and weight using devices external and independent of the Vitals360 device The user then enters the measure...

Page 80: ...ge 80 of 117 2 TAP SELECT the weight and height fields separately while entering the numbers 2 Select to keep the results you entered or select to re enter height and weight 08 4 Illustrated Example of Manually Storing Height ...

Page 81: ...easure the patient s weight using the Bluetooth Weight Scale When this option is chosen the Vitals360 device connects to the weight scale and waits for a measurement When the patient steps on the weight scale the weight scale automatically measures the weight and transmits it to the Vitals360 device which then displays it on the screen The goal of this feature is to measure and save the patient s ...

Page 82: ...t scale and display the reading on the screen The user can now save the weight reading NOTES If the Vitals360 device does not discover the weight scale or is unable to pair with the weight scale then the Vitals360 device allows the user to retry discovering and pairing with the weight scale If the Vitals360 device does not discover the weight scale or is unable to pair with the weight scale then t...

Page 83: ...ht reading from the Bluetooth weight scale the device shall convert the reading value from the measurement unit used by the weight scale to the measurement unit chosen by the user before displaying the reading value on the screen After the Vitals360 device receives a weight reading from the Bluetooth weight scale the device shall disconnect from the weight scale If the device disconnects from the ...

Page 84: ...AMERA 09 1 Overview This VITALS360 device s Camera function can take photos as needed to assist in the evaluation of medical conditions 09 2 Display Symbols Bank 09 3 Illustrated Example of Taking a Picture and Adding in Comments TAKE A PHOTO ...

Page 85: ...the home page Cancel the previous measurement and restart the measuring process 10 2 View the Measuring Result This VITALS360 device s History function can review all the measurements saved in the device Features include a calendar and the following results Blood Pressure Measurement History Blood Oxygen SpO2 Measurement History Heart Rate Measurement History ECG Scanning History Forehead Temperat...

Page 86: ...Instructions for Use Page 86 of 117 10 3 Display Symbols Bank 10 4 Check the History 1 TAP SELECT the History button Unit of the Measurement Date Adjust Button Start Date End Date GRAPH LIST SWITCH ...

Page 87: ...7 2 TAP SELECT the start date of desired date range 3 TAP SELECT the end date of desired date range 4 TAP SELECT the CONFIRM button to view history within the specified date range 5 Choose measurement to be viewed and view trended data ...

Page 88: ...s when you launch and it can be selected to display an instructional video that can help you to learn and understand how to use the VITALS360 device s functions For detail information visit our web site at www vocare com or please contact your local VOCARE INC representative or call 1 855 986 2273 ...

Page 89: ...Instructions for Use Page 89 of 117 12 MODE SWITCHING The VITALS360 device s Switch Modes button allows the user to tap and return to the start up screen in order to choose a desired mode of operation ...

Page 90: ...iquid Be sure to fully shut down the device and disconnect all power cables from the outlets before cleaning the device DO NOT spray anything onto the device DO NOT pour the liquid onto the device DO NOT allow any liquid to seep into the device during cleaning DO NOT get any moisture in slots or openings CAUTION DO NOT clean or disinfect the device while using DO NOT clean the device with any stro...

Page 91: ... broken characters or icons The device will NOT power on Markings on device including labels that are faded coming off or missing Device buttons DO NOT function or are hard to operate If an automatic self test gives an error message NOTES Inaccurate measurements may be caused by autoclaving ethylene oxide sterilizing or immersing the sensors in liquid may cause inaccurate readings The SpO2 Light T...

Page 92: ...Instructions for Use Page 92 of 117 ...

Page 93: ...device should be cleaned and disinfected The area around slots and openings DO NOT get any moisture in slots or openings The device display screen The entire device surface NOTES Allow the device to air dry thoroughly before use If the cable or plug accidentally gets wet rinse them with distilled or deionized water and dry them completely prior to use 13 4 How to Disinfect the Device ...

Page 94: ...S DO NOT use any other cleaning or disinfecting solutions CAUTION Other disinfectants have NOT been tested with the device The effect of other disinfectants used interchangeably has NOT been tested with the device The use of disinfectants other than Super Sani Cloth Wipe s may damage the device The cleaning and disinfecting directions provided should NOT cause any damage or degradation to the exte...

Page 95: ...r physical integrity after cleaning or disinfection CAUTION It is recommended that the Arm Cuff be thoroughly cleaned between uses Care should be taken to keep liquid from entering the Tubes and Inflation Bulb Valve DO NOT press cuff with a hot iron DO NOT use steam or heat to sterilize the cuff or tubing DO NOT use petrol thinners or similar solvents to clean the arm cuff DO NOT wash the arm cuff...

Page 96: ... Adapter cord Supervise children around the device to ensure they DO NOT play with it DO NOT stack with other equipment as this could result in damage or improper operation Check whether safety risks exist regularly and DO NOT use the device if damaged Keep the arm cuff in its original carrying case when NOT in use 1 Unplug the air plug from the air jack 2 Gently fold the air tube into the arm cuf...

Page 97: ... or damp locations Dusty locations Near a source of fire or heat Locations exposed to strong vibration Locations exposed to strong electromagnetic fields DO NOT fold the arm cuff or tubing tightly DO NOT bend or crease the air tube excessively NOTES The housing of the device is NOT UV resistant Keep the device away from water or other liquid Water resistance is NOT a permanent condition and the de...

Page 98: ...of the local government to deal with the used device and the accessories DO NOT dispose of the device in the household waste at the end of its useful life Be aware the device is potentially hazardous electronic scrap e scrap and should be disposed of accordingly Disinfect the device before recycling or discarding CAUTION Please follow the law of the local government regarding used batteries DO NOT...

Page 99: ...117 recycled or disposed of properly Dispose of unwanted electronics through an approved recycler For customer service please visit our web site at www vocare com or contact your local VOCARE INC representative or call 1 855 986 2273 ...

Page 100: ...y 800 by 480 pixel resolution at 458 ppi 2 000 000 1 contrast ratio typical Camera Rear Camera 5MP PDAF Front Camera 2MP FF MIC Yes Speaker Yes 55dBA 80dBA at a Distance of 10 cm Battery Type Non removable Size 1500mAh Charging time 5 Hours Battery recycle Life 300times Power Source 3 7V 1500 mAh or AC adapter optional INPUT AC100 240V 50 60Hz 0 5A max Languages English Australia UK U S Chinese Si...

Page 101: ... 70 89 4 PR range 30 to 150 bpm PR accuracy 2bpm or 2 whichever is greater Body Temperature Technique infrared temperature Measurement site forehead Resolution 0 1 0 1 Measurement range 34 43 93 2 109 4 Measurement Accuracy 0 3 0 5 ECG Measurement method single lead Input impedance 10 MΩ GAIN accuracy 10 Frequency response 0 67 40 HZ GAIN settings 5 mm mV 10 mm mV 20 mm mV ECG speed 25 mm s 50 mm ...

Page 102: ...riate shipping container for examination and servicing The product must be packed carefully to prevent damage in transit Because of possible loss in transit we recommend insuring the product with return receipt requested The foregoing is the sole warranty provided by VOCARE INC in connection with this product and VOCARE INC Hereby disclaims any other warranties express or implied including implied...

Page 103: ...ined in this USER MANUAL The limited warranty is valid ONLY on the presentation of the purchase receipt confirming the date of purchase Opening or altering the device invalidates the limited warranty VOCARE INC reserves the right to make design changes in its products without incurring the obligation to incorporate these changes in products previously delivered VOCARE INC reserves the right to mak...

Page 104: ...amage or alteration 16 4 What s NOT Covered by Warranty A device that is NOT in original condition The shell of the device is broken or cracked Evidence of water damage Accessories or appearance of the device has been abused Evidence of crushing damage to the I R Probe Original package is NOT used during transportation Evidence of non authorized service Unauthorized use of the device If the code l...

Page 105: ...e this service at no charge If the warranty has expired on the device charges may apply 16 6 End User License Agreement for Software This End User License Agreement EULA is a legal agreement between you either an individual or a single entity and VOCARE INC for software owned by VOCARE INC and its affiliate companies and Third Party suppliers and licensors that accompanies this EULA which includes...

Page 106: ...s the media and printed materials any upgrades this EULA and you may NOT retain any copies of the Software The transfer may NOT be an indirect transfer such as a consignment Prior to the transfer the end user receiving the Software must agree to all the EULA terms 6 EXPORT RESTRICTIONS You acknowledge that the Software is subject to export restrictions of various countries You agree to comply with...

Page 107: ...e Arbitration Rules of the U S A Commercial Arbitration Board The award of arbitration shall be final and binding upon the parties 10 ENTIRE AGREEMENT SEVERABILITY This EULA is the entire agreement between you and VOCARE INC relating to the Software and supersedes all prior or contemporaneous oral or written communications proposals and representations with respect to the Software or any other sub...

Page 108: ...f Usability Engineering to Medical Devices AAMI HE75 2009 R2018 Human Factors Engineering Design of Medical Devices IEC 60601 1 6 2010 AMD1 2013 Medical Electrical Equipment Part 1 6 General Requirements for Basic Safety and Essential Performance Collateral Standard Usability IEC 60601 1 2 2014 Medical Electrical Equipment Part 1 2 General Requirements for Safety and Essential Performance Collater...

Page 109: ...s Part 5 Tests For In Vitro Cytotoxicity ISO 10993 10 2010 R 2014 Biological Evaluation of Medical Devices Part 10 Tests for Irritation and Skin Sensitization ISO 10993 11 2018 Biological Evaluation of Medical Devices Part 11 Tests for Systemic Toxicity ISO 14971 2019 Medical Devices Application of Risk Management of Medical Devices ANSI AAMI ISO 15223 1 2016 Medical Devices Symbols to Be Used wit...

Page 110: ...s default htm IMPORTANT INFORMATION REGARDING ELECTRO MAGNETIC COMPATIBILITY EMC With the increased number of electronic devices such as PC s and mobile cellular telephones medical devices in use may be susceptible to electromagnetic interference from other devices Electromagnetic interference may result in incorrect operation of the medical device and create a potentially unsafe situation Medical...

Page 111: ...such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 This VITALS360 device uses RF energy only for its internal function There for its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B This VITALS360 device suitable for use in all establishments including do...

Page 112: ...ontinued operation during power mains interruptions it is recommended that this VITALS360 device be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prio...

Page 113: ...cinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic is affected by absorption and reflection from structures objects and people a The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957...

Page 114: ...evice as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitterm Rated maximum output of transmitter W 150 kHz to 80 MHz outside ISM and amateur radio bands 150 kHz to 80 MHz in ISM and amateur radio bands 80 MHz to 800 MHz 800 MHz to 2 7 GHz 0 01 0 12 0 20 0 035 0 07 0 1 0 38 0 63 0 11 0 22 1 1 2 2 00 0 35 ...

Page 115: ...ermination The Essential Performance of the TEMP is providing an output temperature The Essential Performance of the ECG is heart rate reported These Essential Performances may be affected as a result of exposure to electromagnetic disturbances that are outside of the environments listed in the Indications For Use If issues are experienced move This VITALS360 device away from the source of electro...

Page 116: ...Instructions for Use Page 116 of 117 1 855 986 2273 PO Box 207 Zionsville Indiana 46077 USA www vocare com info vocare com ...

Page 117: ...Instructions for Use Page 117 of 117 ...

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